PHARMAFull-time
Senior Manager GRAAS Operations
By Admin · Regulatory Affairs
HYDERABAD (IN)ONSITEPOSTED: 9/1/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
The Senior Manager, GRAAS Operations is a key leadership position within the Global Submission and Information Management (GSIM) organization.
GSIM focuses on process improvements, digital technologies, data standards, training, and organizational change management to deliver business results.
The role is responsible for executing the strategic vision for Amgen's regulatory technology landscape while leading teams, providing regulatory information management subject-matter expertise, and driving innovation and efficiency.
The position supports continuous improvement of enterprise regulatory systems, streamlined data models, vendor partnerships, regulatory compliance, and measurable business outcomes.
Leadership & Strategic Responsibilities
Execute the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational objectives and regulatory compliance requirements.
Lead a team responsible for implementation, maintenance, and continuous improvement of regulatory information systems and data-management processes.
Provide strategic direction and leadership to regulatory technology and information-management activities.
Drive organizational innovation, efficiency, process improvement, and business-value realization through regulatory technology.
Regulatory Information Management SME
Serve as an in-house Subject Matter Expert on regulatory information management.
Monitor evolving regulatory landscapes, regulatory technology trends, data standards, and industry requirements.
Provide expertise that supports effective regulatory information management and compliant technology adoption.
System Process Simplification
Identify opportunities to simplify and streamline system-based processes and user interfaces.
Improve usability, efficiency, and effectiveness of regulatory information systems.
Support continuous improvement of enterprise regulatory systems and associated data-management processes.
Vendor & Technology Partnership Management
Collaborate with external vendors and technology partners to optimize regulatory-system capabilities.
Influence vendor product roadmaps to ensure technology solutions address organizational needs.
Build effective partnerships that support regulatory compliance, innovation, system performance, and long-term technology strategy.
Data Model & IDMP Expertise
Serve as a regulatory data-model expert with particular focus on Identification of Medicinal Products (IDMP).
Ensure regulatory information aligns with evolving data standards and regulatory requirements.
Support streamlined regulatory data models and improved information-management practices.
Enterprise User Support & Change Enablement
Provide guidance, training, and support to a large enterprise user base.
Enable successful adoption and effective utilization of regulatory information systems.
Support organizational change and user capability development associated with regulatory technology implementations and improvements.
Compliance & Data Security
Ensure regulatory information systems comply with relevant regulatory requirements and standards.
Maintain alignment with applicable data-security protocols.
Support regulatory compliance through appropriate system controls, data standards, and information-management practices.
Preferred Technical Expertise
Advanced knowledge of Enterprise Information Management systems, including ERP and QMS platforms and Change Management.
Familiarity with global regulatory requirements and standards beyond the organization's primary market.
Proficiency in Agile methodologies such as Scrum or Kanban.
Experience with regulatory documents and processes in Regulatory Affairs, Research, Development, Quality Management, or related functions.
Experience implementing large-scale enterprise systems within the biotechnology or pharmaceutical industry.
Education & Experience Requirements
Doctorate degree plus 8 years of regulatory systems experience, OR
Master's degree plus 10 years of regulatory systems experience, OR
Bachelor's degree plus 12 years of regulatory systems experience.
Preferred: 5+ years of experience implementing large-scale enterprise systems in the Biotech/Pharmaceutical industry.
REQUIRED VERIFIED SKILLS
Regulatory Information Management
Regulatory Systems
Regulatory Affairs
Strategic Roadmap Execution
Team Leadership
Regulatory Technology
Subject Matter Expertise
System Process Simplification
Vendor Management
Data Modeling
IDMP
Enterprise Regulatory Systems
Data Management
Regulatory Compliance
Data Security
Enterprise Information Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
The supplied Amgen posting does not provide a salary range, bonus amount, or specific compensation figures, so salary fields are left blank. This is a senior-management regulatory systems position with substantial experience requirements: 8 years with a doctorate, 10 years with a master's degree, or 12 years with a bachelor's degree. Candidates should evaluate the complete Amgen total-rewards package, including base compensation, applicable incentives, benefits, and other senior-level employee programs.
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biopharmaceutical company committed to unlocking the potential of biology for patients suffering from serious illnesses. It discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas with high unmet medical needs such as oncology, cardiovascular disease, bone disease, and inflammatory diseases.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
EXPECTED CAREER ROADMAP
This Senior Manager position provides a strong pathway toward Director and senior leadership roles in Regulatory Information Management, Regulatory Technology, Global Regulatory Operations, Enterprise Data Management, and Digital Transformation. The role builds leadership experience across regulatory systems strategy, IDMP data models, enterprise technology, vendor partnerships, compliance, Agile delivery, and organizational change. Successful delivery can position the candidate for broader global regulatory technology strategy, enterprise transformation, data governance, or regulatory operations leadership roles.
APPLICATION ADVISORY
Clearly demonstrate the education-and-experience combination specified by Amgen. Highlight regulatory systems leadership, enterprise regulatory technology, Regulatory Information Management, IDMP, data modeling, and large-scale system implementation. Show measurable outcomes from process simplification, system modernization, data-quality improvement, regulatory compliance, user adoption, or operational efficiency. Emphasize team leadership and vendor-management experience, including examples where you influenced technology partners or product roadmaps. Highlight ERP, QMS, change-management, Agile/Scrum/Kanban, and global regulatory knowledge where applicable. Prepare leadership examples covering regulatory-system strategy, complex implementations, stakeholder influence, data standards, compliance, user training, organizational change, and continuous improvement.
RECOMMENDED TRAINING
1/5
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